Medical Devices in EU - OEM or OBL?

F

fretcat

#1
hi,

I wonder what if a company in UE produces medical device class I (without measure and not sterile) and I will buy this medical device under my name and my graphic on labels? Who am I? OBL or OEM?
And what if this medical device is not the same as originally produced by the manufacuter? What if is it similar, but not the same? Who am I? OEM?
I wonder what documentation I should receive from the manufacturer who What documents should I receive from them when I am OEM and when I am OBL? Which are necessary for me to prepare technical documentation?
And what about clinical data?

Many thanks for help.
:)
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Class I Medical Device Requirements - Annex VII of the Medical Devices Directive

I wonder what if a company in UE produces medical device class I (without measure and not sterile) and I will buy this medical device under my name and my graphic on labels? Who am I? OBL or OEM?
And what if this medical device is not the same as originally produced by the manufacuter? What if is it similar, but not the same? Who am I? OEM?
I wonder what documentation I should receive from the manufacturer who What documents should I receive from them when I am OEM and when I am OBL? Which are necessary for me to prepare technical documentation?
And what about clinical data?
We need some basic information to understand your many rather open-ended questions.

What is the general nature of the product we're discussing? Where are you located, and where do you market?

If the medical device we're discussing "is not the same as originally produced by the manufacturer", or is similar but not the same, who modified it? What is your regulatory stance such that all of this matters to you?

Rather than asking us to explain the details of every possible product regulatory management question, it would be easier if you would tell us in some detail exactly what you are trying to do. Then we can answer a finite problem.
 
Thread starter Similar threads Forum Replies Date
supadrai Indonesian MOH Regulation Restricting OEM/Private Label Medical Devices Other Medical Device Regulations World-Wide 2
O Certification of OEM Medical Devices EU Medical Device Regulations 12
I What are the Government of India requirements to sell OEM Medical Devices in India? ISO 13485:2016 - Medical Device Quality Management Systems 6
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 1
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
B Procedure packs with non-medical devices EU Medical Device Regulations 1
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
L Shelf life of medical devices Other Medical Device Related Standards 4
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Subcontracting a repair of Medical Devices Canada Medical Device Regulations 0
S Regrind Material in Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Medical Devices Shelf Life ---INDIA Other Medical Device Regulations World-Wide 3
JoCam Warranty of Medical Devices EU Medical Device Regulations 2
R Obsolesce medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational UK - Medicines and Medical Devices Bill 2019-21 UK Medical Device Regulations 0
S Call it refurbish or not? Medical Devices Manufacturing and Related Processes 2
C Registering Medical Devices in Australia and New Zealand - ANZTPA Other Medical Device Regulations World-Wide 0
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
G Accelerated stability of medical devices Other Medical Device Related Standards 1
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
dgrainger Informational Parliament to vote on postponing new requirements for medical devices -17th April Medical Device and FDA Regulations and Standards News 1
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
M Who needs a MDEL? How to buy and sell medical devices on my own Canada Medical Device Regulations 14
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
M Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
M Special Controls and Class II Medical Devices Medical Device and FDA Regulations and Standards News 18

Similar threads

Top Bottom